Sr QA Validation Specialist (Fill Finish)

Our Fill Finish QA Validation team is hiring. As the Senior QA Validation Specialist, you will ensure equipment, systems, and processes meet regulatory standards while adhering to company manufacturing policies and procedures. This role will support our Fill Finish facility in Rensselaer, NY. 

• Equipment Includes: Syringe and Vial Fillers, Lyophilizer, Semi-Automatic and Automatic Inspection, Assembly Machines, Packaging Machines, Serialization, Case Packer and Palletizer 

In this role, a typical day might include the following: 

• Monitor compliance, analyze failures, and assess corrective actions. 

• Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g. Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, CN/PN Change Control) 

• Must be able to present in a “pressure test” scenario the technical area they are SME for 

• Stays current with industry trends, regulatory requirement updates, and motivates changes and improvements based on trends. 

• Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria 

• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria. 

• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. 

• Reviews, edits and approves change controls, SOPs, reports and other documentation 

• Coordinates with other departments or outside contractors/vendors to complete validation tasks. 

• Collaborates with functional departments to resolve issues. 

• Trains/advises less experienced Specialists. 

• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines. 

• Manage and drives projects and prepares status reports. 

• May present at both internal and external (regulatory) audits. 

• May manage full time employees and/or contingent workers. 

• Performs other duties assigned by Management. 

This role may be for you if you: 

• Ability to work independently or as part of a team 

• Ability to communicate with transparency 

• Gathers and organizes information 

• Effective time management skills 

• Seeks to identify continuous improvement needs 

Gowning and Environment 

• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA) 

• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire 

To be considered for this p